CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report

Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter recalled

Medtronic Vascular is recalling Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, distributed nationwide in the US. The recall was initiated on 23 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 0010990608/ GTIN: 00763000232580

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1043-2022
FDA event ID: 89935
Recalling firm: Medtronic Vascular, Santa Rosa, CA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Mar 2022
FDA classified: 6 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

23 Mar 2022	Recall initiated by company
6 May 2022	Classified by FDA	+44 days
18 May 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, PUERTO RICO, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Croatia Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

Which lots are affected?

Lot Number: 0010990608/ GTIN: 00763000232580

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89935

Reported	Class	Recall	Company	Reason	Where
18 May 2022	CLASS II	Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled	Medtronic Vascular	Sterility	Nationwide

More recalls from Medtronic Vascular

All 227

Reported	Class	Recall	Company	Reason	Where
18 May 2022Device	CLASS II	Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled	Medtronic Vascular	Sterility	Nationwide
1 Dec 2021Device	CLASS II	Endurant IIs Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant II Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
4 Aug 2021Device	CLASS II	Medtronic Endurant IIs Stent Graft System Medtronic recalled	Medtronic Vascular	Other	8 states

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